POSSIBLE SIDE EFFECTS
Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of your treatment. Remember, you should always speak to a member of your healthcare team if you have any questions.
ABOUT KEYTRUDA
ALL MEDICINES CAN CAUSE SIDE EFFECTS
You may experience side effects while taking KEYTRUDA. Side effects are usually manageable, but in some cases these side effects can become life-threatening and can lead to death. These side effects may happen any time during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.
It is important to tell your doctor or nurse straight away if you experience any of the symptoms listed below. Some people may have side effects that mean they cannot continue treatment.
In some cases, depending on the type of cancer you have, you may be given KEYTRUDA in combination with another medicine. It is important that you also read the Consumer Medicine Information for any other medicine given in combination with KEYTRUDA.
Serious side effects
Call or see your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Signs and symptoms of lung problems
- shortness of breath
- chest pain
- coughing
Signs and symptoms of problems with your intestines
- diarrhoea or more bowel movements than usual
- your stools are black, tarry, sticky or have blood or mucus
- severe stomach pain or tenderness
Signs and symptoms of liver problems
- nausea or vomiting
- pain on the right side of your stomach
- the whites of your eyes look yellow
- you bleed or bruise more easily than normal
- feeling less hungry
- your skin looks yellow
- dark urine
Signs and symptoms of kidney problems
- changes in the amount or colour of your urine
Signs and symptoms of hormone gland problems (especially the thyroid, pituitary, and adrenal glands)
- rapid heart beat
- increased sweating
- hair loss
- constipation
- muscle aches
- headaches that will not go away or unusual headache
- weight loss
- weight gain
- feeling cold
- your voice gets deeper
- dizziness or fainting
Signs and symptoms of blood sugar problems
- feeling more hungry or thirsty
- weight loss
- needing to urinate more often
Signs and symptoms of skin problems
- rash
- skin blistering, peeling or sores
- itching
- ulcers in mouth or in lining of nose, throat, or genital area
Signs and symptoms of problems in other organs
- muscle pain or weakness
- changes in eyesight
- stomach area pain with nausea and vomiting (pancreatitis)
- confusion, fever, memory problems, or seizures (encephalitis)
- swollen lymph nodes, rash or tender lumps on skin, cough, or eye pain (sarcoidosis)
- shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)
- inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired, or chest pain (pericarditis)
- inflammation of the covering of the heart and accumulation of fluid around the heart (pericardial effusion)
- inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs (peripheral neuropathy)
- pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis)
- inflammation of the blood vessels (vasculitis)
- decreased function of the parathyroid gland, which may include muscle cramps or spasms, fatigue and weakness (hypoparathyroidism)
- inflammation of the stomach lining, which may include severe stomach pain or tenderness, nausea or vomiting (gastritis)
- destruction of red blood cells, which may include dark urine, pale or yellow skin/eyes, lightheadedness, feeling tired, rapid heartbeat, or shortness of breath (haemolytic anaemia)
- pain in the upper right part of the stomach, swelling of the liver or spleen, fatigue, itching or yellowing of the skin or the whites of the eyes (sclerosing cholangitis)
- decreased ability of the pancreas to make digestive enzymes, which may include diarrhoea with loose and oily stools, weight loss, metabolic bone disease, and vitamin or mineral deficiencies (exocrine pancreatic insufficiency)
Signs and symptoms of infusion (IV) reactions
- shortness of breath
- dizziness
- itching or rash
- fever
There are possible side effects of treatment with KEYTRUDA in people who have received a transplant:
- Rejection of a transplanted organ
- People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host-disease, in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic)
- These complications can be severe and can lead to death. They may occur if you had this kind of transplant in the past or if you get it in the future. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhoea.
Common side effects
Speak to your doctor if you have any of these side effects and they worry you.
The following side effects have been reported in clinical trials:
Very common (may affect more than 1 in 10 people)
- diarrhoea
- nausea
- joint pain
- feeling tired
- patches of skin which have lost colour
- decreased sodium levels in the blood
- infections of the upper respiratory tract
- low levels of thyroid hormone
- itching
- rash
- back pain
- cough
- stomach pain
- fever
- a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma
In some cases, depending on the type of cancer you have, you may be given KEYTRUDA in combination with another medicine.
The following side effects have been reported in more than 1 in 5 people when KEYTRUDA was given in combination with chemotherapy:
- hair loss
- feeling tired
- diarrhoea
- vomiting
- rash
- fever
- decrease in white blood cell count
- decreased appetite
- joint pain
- swelling of the lining of the digestive system (for example mouth, intestines)
- mouth sores
- decrease in red blood cell count
- nausea
- constipation
- weight loss
- decrease in number of platelets in the blood
- elevated liver enzymes
Common side effects when KEYTRUDA is given in combination with lenvatinib include:
- low levels of thyroid hormone
- high blood pressure
- feeling tired
- diarrhoea
- joint and muscle pain
- nausea
- decreased appetite
- vomiting
- mouth sores
- weight loss
- stomach-area (abdominal) pain
- urinary tract infection
- protein in your urine
- constipation
- headache
- bleeding
- blisters or rash on the palms of your hands and soles of your feet
- hoarseness
- rash
The most common side effects when KEYTRUDA is given in combination with axitinib are:
- diarrhoea
- high blood pressure
- low levels of thyroid hormone
- blisters or rash on the palms of your hands and soles of your feet
- mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
- rash
- fatigue
- liver problems
- decreased appetite
- nausea
- hoarseness
- cough
- constipation
The most common side effects when KEYTRUDA is given alone to children are:
- fever
- vomiting
- headache
- stomach area (abdominal) pain
- decrease in number of red blood cells
- cough
Less common side effects can happen.
Other side effects not listed here may occur in some people.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Ask your doctor to answer any questions you may have.
References
KEYTRUDA Australian Consumer Medicine Information, www.msdinfo.com.au/keytrudacmi.
For further information about your condition or treatment consult your healthcare professional or refer to the Consumer Medicine Information for KEYTRUDA.
AU-KEY-00557 (v10.0). Issued September 2024.
MSD Medical Information or to report product complaints (including adverse events): 1800 818 553
This educational website is sponsored by Merck Sharp & Dohme (Australia) Pty Ltd. Information displayed on this website is only intended for Australian residents who are 18 years or older and are currently being treated with KEYTRUDA and as such, its contents have been designed to comply with Australian laws and regulations. The information on this website is educational only and is not intended to be used for any self-diagnosis purposes nor to replace the advice of your Doctor or healthcare professional. Please consult your Doctor or healthcare professional for further information on KEYTRUDA. Use and access of this website is subject to the terms and conditions set out in our Legal Agreement and Privacy Policy.
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AU-KEY-00559. Issued March 2024.
